CARPROFEN tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARPROFEN (UNII: FFL0D546HO) (CARPROFEN - UNII:FFL0D546HO)

Available from:

Cronus Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Carprofen Chewable Tablets are indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. Carprofen Chewable Tablets should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Product summary:

STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [See USP controlled room temperature.] Protect from light. HOW SUPPLIED: Carprofen Chewable Tablets are scored (except for the unscored 37.5 mg strength), and contain 25 mg, 50mg, 37.5 mg, 75 mg, or 100 mg of carprofen per tablet. Each tablet size is packaged in bottles containing 60 or 180 tablets.

Authorization status:

Abbreviated New Animal Drug Application

Patient Information leaflet

CARPROFEN- CARPROFEN TABLET, CHEWABLE
Cronus Pharma LLC
----------
Dog Owner Information about Carprofen Chewable Tablets (carprofen) for
Osteoarthritis and Post-Surgical
Pain
This summary contains important information about Carprofen Chewable
Tablets. You should read this
information before you start giving your dog Carprofen Chewable
Tablets and review it each time the
prescription is refilled. This sheet is provided only as a summary and
does not take the place of instructions
from your veterinarian. Talk to your veterinarian if you do not
understand any of this information or if you
want to know more about Carprofen Chewable Tablets.
What are Carprofen Chewable Tablets?
Carprofen Chewable Tablets are a nonsteroidal anti-inflammatory drug
(NSAID) that is used to reduce pain
and inflammation (soreness) due to osteoarthritis and pain following
surgery in dogs. Carprofen Chewable
Tablets is a prescription drug for dogs. It is available as a chewable
tablet and is given to dogs by mouth.
Osteoarthritis (OA) is a painful condition caused by “wear and
tear” of cartilage and other parts of the joints
that may result in the following changes or signs in your dog:
•
Limping or lameness
•
Decreased activity or exercise (reluctance to stand, climb stairs,
jump or run, or difficulty in
performing these activities)
•
Stiffness or decreased movement of joints
To control surgical pain (e.g. for surgeries such as spays, ear
procedures or orthopedic repairs) your
veterinarian may administer Carprofen Chewable Tablets before the
procedure and recommend that your dog
be treated for several days after going home.
What kind of results can I expect when my dog is on Carprofen Chewable
Tablets?
While Carprofen Chewable Tablets are not a cure for osteoarthritis, it
can relieve the pain and inflammation
of OA and improve your dog’s mobility.
•
Response varies from dog to dog but can be quite dramatic.
•
In most dogs, improvement can be seen in a matter of days.
•
If Carprofen Chewable Tablets are discontinued or not

Summary of Product characteristics

CARPROFEN- CARPROFEN TABLET, CHEWABLE
CRONUS PHARMA LLC
----------
CARPROFEN CHEWABLE TABLETS
(CARPROFEN)
_NON-STEROIDAL ANTI-INFLAMMATORY DRUG_
FOR ORAL USE IN DOGS ONLY
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION:
Carprofen Chewable Tablets (carprofen) are a non-steroidal
anti-inflammatory drug
(NSAID) of the propionic acid class that includes ibuprofen, naproxen,
and ketoprofen.
Carprofen is the nonproprietary designation for a substituted
carbazole, 6-chloro-α-
methyl-9H-carbazole-2-acetic acid. The empirical formula is C
H
ClNO and the
molecular weight 273.72. The chemical structure of carprofen is:
Carprofen is a white, crystalline compound. It is freely soluble in
ethanol, but practically
insoluble in water at 25°C.
CLINICAL PHARMACOLOGY
Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent
with characteristic
analgesic and antipyretic activity approximately equipotent to
indomethacin in animal
models .
The mechanism of action of carprofen, like that of other NSAIDs, is
believed to be
associated with the inhibition of cyclooxygenase activity. Two unique
cyclooxygenases
have been described in mammals . The constitutive cyclooxygenase,
COX-1,
synthesizes prostaglandins necessary for normal gastrointestinal and
renal function.
The inducible cyclooxygenase, COX-2, generates prostaglandins involved
in
inflammation. Inhibition of COX-1 is thought to be associated with
gastrointestinal and
renal toxicity while inhibition of COX-2 provides anti-inflammatory
activity. The specificity
of a particular NSAID for COX-2 versus COX-1 may vary from species to
species . In an
_in vitro_ study using canine cell cultures, carprofen demonstrated
selective inhibition of
COX-2 versus COX-1.
Clinical relevance of these data has not been shown. Carprofen
has also been shown to inhibit the release of several prostaglandins
in two inflammatory
cell systems: rat polymorphonuclear leukocytes (PMN) and human
rheumatoid synovial
cells, indicating inhibition o